The Medicines (Products for Human Use) (Fees) Regulations 2016

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations revoke and re-enact, with some amendments, the Medicines (Products for Human Use) (Fees) Regulations 2013 (“the 2013 Regulations”). They make amendments to the Medical Devices (Consultation Requirements) (Fees) Regulations 1995 (“the 1995 Regulations”).

These Regulations make provision for the fees payable under the Medicines Act 1971 and other fees payable in respect of EU obligations including those relating to authorisations, licences, certificates and registrations in respect of medicinal products for human use.

The fees prescribed in the Regulations are reviewed on an annual basis and based on an assessment of the costs associated with a range of licensing requirements and functions. The fee amounts specified in these Regulations are set in line with a consultation document issued by the Medicines and Healthcare products Regulatory Agency (“MHRA”) on 22nd October 2015. A summary of the consultation responses is published on the MHRA’s website (www.mhra.gov.uk).

In general the majority of fees have been reduced by between 5-15% to ensure that they reflect the costs for the MHRA in carrying out related regulatory activity. These Regulations also include new provisions to implement the fees necessary to carry out regulatory activities in relation to online sellers of medicines.

Parts 2 to 9 and 11 and 12 and Schedules 2 and 3 provide for capital fees to be payable in connection with pre-application meetings; applications for, or variations to, authorisations, manufacturer’s licences, wholesale dealer’s licences, clinical trial authorisations, broker registrations, active substance registrations, traditional herbal registrations and certificates permitting the export of medicinal products; applications to be included on the list of online sellers of medicines; assistance in obtaining or renewing marketing authorisations in other EEA States; the assessment of labels and leaflets; renewals of certain manufacturer’s licences; and inspections. Most of the fees were previously provided for by the 2013 Regulations.

Part 10 and Schedule 4 provide for periodic fees in connection with authorisations, registrations and licences as well as for persons included on the list of online sellers of medicines.

Part 13 and Schedule 5 provides for fees in relation to homoeopathic medicinal products.

Part 14 and Schedules 6, 7 and 8 deal with the time for payment and waiver or refund of both capital and periodic fees in specified circumstances.

Part 15 makes consequential amendments to the Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004 to update cross-references to these Regulations. In addition it amends the 1995 Regulations by reducing the amounts of the fees specified in regulations 3 and 3A of those Regulations.

Part 16 of these Regulations revokes the 2013 Regulations.

A full impact assessment of the effect that this instrument will have on the costs of business and the voluntary sector is available from the Medicines and Healthcare products Regulatory Agency, 151 Buckingham Palace Road, Victoria, London SW1W 9SZ and is published with the Explanatory Memorandum alongside the instrument on www.legislation.gov.uk.